Here are the answers I received this morning for mr Donenburg
Hi Ms Swanson,
Hope this finds you doing well. A couple of questions for you regarding Biosante Pharm in am obviously pleased at the recent announcement to conduct another efficacy trial ! If you can please answer the following questions,
1] Any idea when we can expect 9th safety review ? then how long until top line safety ?
The 9th safety review should occur during the third quarter. The top-line safety report is targeted for year-end 2012.
2] When will Teva launch Bio T Gel ?
We do not know.
3] Have any of the lawsuits been resolved ?
We do not know to what lawsuits you are referring.
4] Is there anything that would prevent insiders to buy share at this time ? [ i.e pending 9th safety ]
We do not comment on whether or not insiders can or cannot buy at any given time.
5] Can you comment on why Bpax appears to be in "quiet mode" I noticed less PR than usual lately.
We have and will continue to issue news releases as appropriate.
6] Is it possible for Bpax to file for a NDA upon / assuming safety results are proven ? For FSD
7] Can BPAX use the CV benefits in safety trial, to file for a NDA for use in lowering CV ? or will they have to conduct a new trial specifically for CV.
A decision on this issue only can be made at the conclusion of the LibiGel safety study.
8] I have read FDA article 505 .......where the FDA has used other trials that have proven i.e. efficacy as P & G had ......and used data as part of a NDA for a drug..Is it possible to use for NDA for Libi .....again assuming SAFETY is proven.
This question is not clear to us and therefore we cannot answer.
9] Will the new trial for efficacy be for both FSD and HSDD ?
HSDD is a subcomponent of FSD.
I am including Mr Donenburg in this e mail.....
Any feedback would be greatly appreciated.